D-0094-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2024
- Initiation Date
- November 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,864 bottles
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
Reason for Recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025